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U.S. Department of Health and Human Services

Class 2 Device Recall Dunlee DA 200 Ultra & MX 200 Ultra CT XRay Tube Housing Assembly

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 Class 2 Device Recall Dunlee DA 200 Ultra & MX 200 Ultra CT XRay Tube Housing Assemblysee related information
Date Initiated by FirmApril 07, 2005
Date PostedMay 13, 2005
Recall Status1 Terminated 3 on October 20, 2005
Recall NumberZ-0840-05
Recall Event ID 31457
Product Classification Assembly, Tube Housing, X-Ray, Diagnostic - Product Code ITY
ProductDunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01
Code Information Model DA 200 Ultra and MX200 Ultra, part number 887-01, serial (anode) numbers 18986, 18987, 18988, 18996, 19000, 19004, 21799, 21801, 21841, 21844, 23107, 23116, 23117, 23121, 23124, 23125, 23126, 23137, 23139, 23525, 23529, 23536, 23537, 23538, 23541, 23542, 23544, 23545, 23548, 23550, 23552, 23883, 23884, 23894, 23895, 23906, 23908
FEI Number 1483239
Recalling Firm/
Manufacturer		 Dunlee
555 Commerce St
Aurora IL 60504-8110
For Additional Information ContactMr. John M. Macko
800-238-3780
Manufacturer Reason
for Recall		The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
FDA Determined
Cause 2		Other
ActionDunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.
Quantity in Commerce37 units
DistributionNationwide and internationally to Taiwan, Germany and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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